UniCycive Therapeutics Inc (UNCY)

[Whalatane]

For re inspections the FDA has a Final 60 day rule . FDA will determine if the facility cleared inspection at least 30-60 days before the PDUFA date ...June 29th .
So we are near the end of that window ......deadline May 29th .
FDA on site inspectors will notify plant immediately of their decision and then follow up with a notification to UNCY thru FDA formal channels
If there are issues still to be resolved FDA will issue Form 483 ...listing the issues .

If no Form 483 is issued its a very positive sign for UNCY that they will receive a clean notice .
So we should know within the next 18 days.

Above just my understanding of how this works

The Co in India is supposed to know immediately following the inspection . If theres a problem UNCY will probably wait until they receive the formal Form 483 ...and then can even wait 4 business days to disclose I think .
However this info is often leaked ...so watch the stock direction and trading volume over next week or so .
FDA will normally want 3-4 wks to finalize the labeling ...and what UNCY can include on the label ...so re inspection decision is imminent
JMO
Kiwi